Efforts to personalize regenerative approaches, therapeutics, and biomedical devices are catalyzing major advances in the treatment of serious injuries and chronic diseases. State of the art efforts in personalized medicine, which are common within certain areas in the biomedical space (e.g., dentistry), now extend toward development of patient-specific tissues and organs, drug screening approaches, and advanced biomedical devices (e.g., advanced prosthetics and biointerfaces). Customization of medical treatments could convey significant advantages by targeting treatment directly to a specific injury or disease profile of a patient, which is critical due to inherent variance in patient anatomies, injury profiles, and genetic and proteomic structures. Recent advances in genome and proteome mapping are enabling advances in personalized treatment approaches at the molecular level. Yet, it remains a critical challenge to provide customized treatments at the tissue level that address patient-to-patient variances in disease and injury profiles, particularly in neuroregeneration.
Nerve regeneration is a complex biological phenomena that often requires a balance of molecular- and tissue-level repair strategies, depending on the nature of the particular injury or neurological disorder. Peripheral nerve regeneration is a particularly important concern, as damage to peripheral nerves occurs via various mechanisms, including disease and traumatic accidents such as car accidents and battlefield wounds, resulting in greater than 200,000 annual nerve repair procedures performed in the U.S. alone. Conventional nerve repair techniques center on grafting approaches, such as autografts and decellularized allografts, which have the major advantages of closely mimicking natural nerve characteristics. However, grafting approaches also present various drawbacks and limitations, including the need for an additional harvesting surgery, chronic pain and morbidity at the donor site, limitations on graft size and geometry, and potential immune response. This has motivated alternative nerve repair strategies, such as the use of nerve guidance channels constructed from synthetic and biological polymers, which provide a geometric tubular pathway for the reconnection and regeneration of damaged nerves.
Nerve guidance channels possess various advantages, including flexibility in material choice, avoidance of additional surgeries, and the ability to augment guide characteristics with physical, cellular, and biochemical functionalities. Existing nerve guide technologies have facilitated the regeneration of short linear nerve injuries, but the technology is hindered in its application to more complex injuries. This is because the nerve guidance channel manufacturing approaches, such as molding, solid-liquid phase-separation, electrospinning, and lyophilizing, rely on structure-providing scaffolds that are later removed. This significantly hinders the ability to achieve complex 3D geometries and incorporate supporting biomodalities. Thus, the development of a one-pot biomanufacturing approach to nerve guide design and fabrication, which enables programmable, complex geometries and biomimetic augmentation, may significantly expand the scope of nerve channel-based regeneration strategies.
There is a need in the art for novel compositions and methods for promoting nerve regeneration in a mammal in need thereof. In certain embodiments, such compositions and methods should allow for the regeneration of multiple and complex nerve pathways. The present invention meets this need.